Senior Associate Manufacturing - New Product Introduction Systems (Multiple Positions)

Location: Holly Springs, North Carolina, United States

Company

hirify.global is a biotechnology company developing and manufacturing medicines for patients worldwide.

What you will do

• Coordinate New Product Introduction programs for the biologics drug substance manufacturing plant.
• Facilitate Quality Risk Assessments, including planning, structured discussions, documentation, and approvals.
• Prepare and maintain QRA reports, FMEAs, risk action logs, and continuous improvement records.
• Create and reconcile process Bills of Materials across Supply Chain, MES, Single-Use Systems, Manufacturing, and other functions.
• Own assigned Change Control records, including impact assessments, implementation planning, and lifecycle management.
• Track dependencies, deadlines, evidence, and deliverables while providing readiness updates and escalating risks.

Requirements

• Master's degree, or a bachelor's degree with 4 years of Manufacturing or Operations experience.
• Alternatively, an associate's degree with 8 years of experience, or a high school diploma/GED with 10 years of experience.
• Experience in GMP manufacturing or manufacturing support, preferably in biotechnology or pharmaceuticals.
• Experience with cross-functional coordination, risk assessments or FMEAs, technical writing, and compliant documentation.
• Ability to manage multiple priorities, maintain trackers, follow up on actions, and escalate risks.
• Strong written and verbal communication skills in a matrix environment.

Nice to have

• Experience with Veeva QMS, TrackWise, Change Controls, CAPAs, deviations, or risk-related quality records.
• Experience maintaining manufacturing Bills of Materials and coordinating material readiness.
• Knowledge of drug substance manufacturing, electronic batch records, and MES.
• Degree in Science, Engineering, Supply Chain, Operations, or a related field.

Culture & Benefits

• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus and stock-based long-term incentives.
• Paid time off and biannual company-wide shutdowns.
• Flexible work models, including remote arrangements where possible.